Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury

NCT06723561 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: PRO 51429
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. The main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury. Hypothesis 1: LDN will decrease the severity of CNP in adult patients with SCI as measured by the Neuropathic Pain Scale (NPS) Hypothesis 2: LDN will improve quality of life of patients with SCI as measured by various validated clinical tools There is no comparison group. This study is being completed to give investigators more information for how to best run a larger clinical trial. Participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks.

Conditions

Spinal Cord Injury; Central Neuropathic Pain

Keywords

Central Neuropathic Pain; CNP; Spinal Cord Injury; SCI; Naltrexone; Low Dose Naltrexone; LDN

Outcome Measures

Primary Outcomes (1)

• Evaluate LDN in the treatment of CNP after SCI

  Generate initial data to calculate an effect size of LDN in the treatment of CNP in SCI. This will be utilized to plan a randomized control trial and submit for extramural funding.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (5)

• Evaluate improvement in quality of life using the Average Daily Pain Score (ADPS).

  From enrollment to the end of treatment at 12 weeks

• Evaluate improvement in quality of life using Daily Sleep Interference Scale (DSIS)

  From enrollment to the end of treatment at 12 weeks

• Evaluate improvement in quality of life using the Patient Global Impression of Change (PGIC)

  From enrollment to the end of treatment at 12 weeks

• Evaluate improvement in quality of life using the Neuropathic Pain Scale (NPS).

  From enrollment to the end of treatment at 12 weeks

• Evaluate improvement in quality of life using the Spinal Cord Injury Quality of Life Pain Interference Scale (SCI-QOL).

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Low Dose Naltrexone

EXPERIMENTAL

Daily dose of 4.5mg of naltrexone

Drug: 4.5mg daily dose of naltrexone

Interventions

4.5mg daily dose of naltrexone DRUG

Study subjects will take a daily 4.5mg dose of naltrexone.

Low Dose Naltrexone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of a traumatic cervical or thoracic spinal cord injury
• Age ≥18
• \>6 months from time of injury
• Central neuropathic pain related to SCI, based on evaluation of a Physical Medicine \& Rehabilitation Physician
• DN4 questionnaire ≥ 4
• English speaking

You may not qualify if:

• Adjustment in pain medications within the previous month
• Chronic opioid treatment
• Current treatment with naltrexone or other opioid antagonist
• Allergy to naltrexone
• Central neuropathic pain attributed to other etiology
• Neuropathic pain attributed to the peripheral nervous system
• PHQ9 ≥15 indicating moderately severe or severe depressive symptoms
• Documented traumatic brain injury that would affect study participation, in the opinion of the investigator
• Scheduled elective surgery during the duration of the study
• Pregnant or breastfeeding
• Illicit substance use per Wisconsin law

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 9, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)